Autonomic Dysfunction in Neuromyelitis Optica Spectrum Disorder and Multiple Sclerosis : A Comparative Study

N/ANot Yet RecruitingNCT07273292

Mohamed Moshref abd alsattar100 enrolled

Overview

To compare the frequency and patterns of autonomic dysfunction in patients with NMOSD and MS, and to investigate its correlations with clinical disability, radiological findings, fatigue, and quality of life parameters

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

NMO and MS

Interventions

Bedside cardiovascular reflex testsDIAGNOSTIC_TEST

These tests evaluate both parasympathetic and sympathetic components of cardiovascular regulation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients (≥18 years , both sexes. * Confirmed diagnosis of NMOSD according to the 2015 International Consensus Criteria. * Confirmed diagnosis of RRMS according to the 2024 McDonald diagnostic criteria. Exclusion Criteria: * Comorbidities affecting autonomic function (e.g., diabetes, Parkinsonism). * Medications known to interfere with autonomic testing. * Cognitive impairment precluding questionnaire completion.

Outcomes

Primary Outcomes

Prevalence of autonomic dysfunction in Neuromyelitis Optica Spectrum Disorder

Autonomic dysfunction assessment using COMPASS-31 questionnaire (Arabic validated version) (12):The Composite Autonomic Symptom Score 31 (COMPASS-31) is a validated, self-administered questionnaire derived from the original 169-item Autonomic Symptom Profile. It provides a concise yet comprehensive evaluation of autonomic symptoms across six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor functions. The total weighted score ranges from 0-100, with higher scores reflecting greater autonomic symptom burden.

Time frame: Baseline

Secondary Outcomes

Correlations with disability, MRI findings, fatigue, and quality of life.

D. Fatigue and psychiatric symptoms * Fatigue Severity Scale (FSS): Nine-item scale measuring the impact of fatigue on physical, occupational, and social functioning. Widely validated in MS and NMOSD cohorts. * Hamilton Depression Rating Scale (HAM-D)\&Hamilton Anxiety Rating Scale (HAM-A): Clinician-administered tools that quantify depression and anxiety severity, respectively. Inclusion is important given the known bidirectional relationship between autonomic dysfunction and mood disorders. E. Quality of life. o The SF-36 is a generic health-related quality of life tool with 36 items covering eight domains (physical functioning, role limitations due to physical/emotional health, pain, vitality, mental health, social functioning, and general health). A. Neuroimaging: Brain and Spinal MRI o MRI will be reviewed for lesion load (number and volume) and lesion topography (anatomical distribution). Assessments will be performed by a neuroradiologist blinded to clinical

Time frame: baseline

Central Contacts

Mohamed Moshref Abd alsattar, Master

CONTACT

0201068960922 mohamedmshrf47@gmail.com

Data from ClinicalTrials.gov

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